Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

Open-Label Extension of Studies ATH-1017-AD-0201 and ATH-1017-AD-0202 in Subjects With Mild to Moderate Alzheimer's Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04886063
• Other study ID #: ATH-1017-AD-0203
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: June 30, 2021
• Est. completion date: February 2027

Study information

• Verified date: February 2023
• Source: Athira Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the safety and tolerability of fosgonimeton (ATH-1017) in subjects with mild to moderate Alzheimer's disease who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202.

Description:

This is a multicenter, seamless, open-label extension (OLEX) study of ATH-1017 treatment in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease who completed 26 weeks treatment in the randomized, placebo-controlled, double-blind studies, ATH-1017-AD-0201 and ATH-1017-AD-0202. This OLEX study will provide additional, longer-term safety and tolerability information on ATH-1017 administration up to 30 months in subjects with mild to moderate Alzheimer's disease.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 450
• Est. completion date: February 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subject has completed the Week 26 visit of either of the two blinded parent studies (ATH-1017-AD-0201 or ATH-1017-AD-0202).
• Reliable and capable support person/caregiver who is willing to accept responsibility for supervising the daily treatment or, if required, administering study drug.
• Subject capable of giving signed informed consent, or by a legally acceptable representative.
• Subjects must be in generally good health.
• Male subjects and their partners must agree to continue to use a double-barrier method of contraception during the study, including the follow-up period, unless the partner is not of childbearing potential.

Exclusion Criteria:

• Subject has experienced a serious adverse event during the parent study, which could present an increased safety risk during the open label extension.
• New diagnosis of severe major depressive disorder even without psychotic features.
• Any subject with formalized delusions or hallucinations.
• Significant suicide risk.
• Newly-diagnosed malignant tumor, except for the following conditions that are stable

in the judgement of the investigator:

• Adequately treated squamous and basal cell carcinoma, or squamous and basal cell carcinoma in situ
• Prostate carcinoma in situ

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• ATH-1017
Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe

Locations

Country	Name	City	State
Australia	St Vincent's Centre for Applied Medical Research, Translational Research Centre	Darlinghurst	New South Wales
Australia	Hammondcare Greenwich Hospital	Greenwich	New South Wales
Australia	KaRa MINDS	Macquarie Park	New South Wales
Australia	HammondCare	Malvern	Victoria
Australia	Australian Alzheimer's Research Organization	Nedlands	Western Australia
United States	Neurological Associates of Albany	Albany	New York
United States	Albuquerque Neuroscience Inc.	Albuquerque	New Mexico
United States	JEM Research Institute	Atlantis	Florida
United States	Senior Adults Specialty Research	Austin	Texas
United States	Insight Clinical Trials, LLC	Beachwood	Ohio
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Massachusetts General Hospital	Charlestown	Massachusetts
United States	Atrium Health Department of Psychiatry	Charlotte	North Carolina
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	Rush Alzheimer's Disease Center, Rush University Medical Center	Chicago	Illinois
United States	Neurology Clinical, P.C.	Cordova	Tennessee
United States	ATP Clinical Research, Inc	Costa Mesa	California
United States	Neurology Diagnostics	Dayton	Ohio
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	Brain Matters Research	Delray Beach	Florida
United States	Mile High Research Center	Denver	Colorado
United States	Duke Neurology Research	Durham	North Carolina
United States	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island
United States	Neuropsychiatric Research Center of SW Florida	Fort Myers	Florida
United States	Neurology Center of North Orange County	Fullerton	California
United States	Hackensack Meridian Hackensack University Medical Center	Hackensack	New Jersey
United States	Hawaii Pacific Neuroscience, Memory Disorders Center & Alzheimer's Research	Honolulu	Hawaii
United States	IU Health Neuroscience Center	Indianapolis	Indiana
United States	Evergreen Health Research Program	Kirkland	Washington
United States	Cleveland Clinic Lou Ruvo Center for Brain Health	Las Vegas	Nevada
United States	Activmed Practices & Research, Inc.	Lowell	Massachusetts
United States	ClinCloud	Maitland	Florida
United States	AMC Research, LLC	Matthews	North Carolina
United States	Merrit Island Medical Research	Merritt Island	Florida
United States	Manhattan Behavioral Medicine, PLLC	New York	New York
United States	Keystone Clinical Studies	Norristown	Pennsylvania
United States	Neurobehavioral Clinical Research	North Canton	Ohio
United States	Xenoscience	Phoenix	Arizona
United States	Progressive Medical Research	Port Orange	Florida
United States	Center for Cognitive Health	Portland	Oregon
United States	Summit Research Network Inc.	Portland	Oregon
United States	Global Medical Institutes LLC; Princeton Medical Institute	Princeton	New Jersey
United States	University of Rochester-AD-CARE Program	Rochester	New York
United States	iResearch Savannah	Savannah	Georgia
United States	University of Washington	Seattle	Washington
United States	Northwest Neurological	Spokane	Washington
United States	SIU Medicine Neuroscience Institute (NSI)	Springfield	Illinois
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	Advanced Memory Research Institute of NJ	Toms River	New Jersey
United States	Premiere Research Institute	West Palm Beach	Florida
United States	Grayline Research Center	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Athira Pharma

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Description - To determine the safety and tolerability of ATH-1017 over an additional 130-week period in subjects with mild to moderate Alzheimer's disease (AD) who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202	130 Weeks